WO2015163966A1 - Système et procédé pour guides d'implantation imprimés en trois dimensions - Google Patents

Système et procédé pour guides d'implantation imprimés en trois dimensions Download PDF

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Publication number
WO2015163966A1
WO2015163966A1 PCT/US2015/014374 US2015014374W WO2015163966A1 WO 2015163966 A1 WO2015163966 A1 WO 2015163966A1 US 2015014374 W US2015014374 W US 2015014374W WO 2015163966 A1 WO2015163966 A1 WO 2015163966A1
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WIPO (PCT)
Prior art keywords
guide
defect
printed
osteochondral
bone
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PCT/US2015/014374
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English (en)
Inventor
Frank J. KOSAREK
Michelle L. RIVERA
Frank J. KOSAREK, Jr.
Original Assignee
Kosarek Frank J
Rivera Michelle L
Kosarek Frank J Jr
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Application filed by Kosarek Frank J, Rivera Michelle L, Kosarek Frank J Jr filed Critical Kosarek Frank J
Priority to US14/646,263 priority Critical patent/US20150351916A1/en
Publication of WO2015163966A1 publication Critical patent/WO2015163966A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A61B17/1767—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee for the patella
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1771—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the ear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/02—Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A61B6/03—Computed tomography [CT]
    • A61B6/032—Transmission computed tomography [CT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0875—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30756—Cartilage endoprostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4618—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of cartilage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30756—Cartilage endoprostheses
    • A61F2002/30762—Means for culturing cartilage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30756—Cartilage endoprostheses
    • A61F2002/30764—Cartilage harvest sites
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]

Definitions

  • the present invention relates generally to a process for fabricating size- specific, customized bio-printed musculoskeletal tissue using three dimensional data collected from radiologic imaging.
  • the present invention also relates to a guide that is created from radiological imaging that demarcates the area of surgical interest.
  • the guide is 3D printed according to guide dimensions collected from radiological imaging, including, but not limited to, CT imaging scans, CT arthrography, ultrasound, MRI, MR arthrography, or any other imaging modality used to image the musculoskeletal system.
  • Bioprinting is a novel science which produces the automated fabrication of human tissue and organs using a three-dimensional (“3D") bioprinter.
  • tissues are created by using living cells as tiny building blocks and printing these blocks along with matrix on to sheets of biopaper.
  • highly cellular tissues are generated in bioprinting by the precise placement of cells and matrix simultaneously on sheets of biopaper. These sheets of cells and matrix are stacked one upon the other in order to fabricate a 3D organ or tissue.
  • ALLOgraft can be fresh cadaveric osteochondral ALLOgraft material or fresh frozen osteochondral ALLOgraft material. Both of these osteochondral ALLOgraft materials are problematic for several reasons.
  • Fresh cadaveric ALLOgraft material is difficult to obtain from a donor patient as it has to be acquired and implanted in a short period of time from the deceased donor to the recipient. This leads to logistic problems related to speedy harvest and delivery of the fresh cadaveric ALLOgraft material. To address this problem, fresh frozen ALLOgraft cadaveric material has been used, however, it is problematic because it has been frozen, the cartilage and osseous cell viability within the tissue is decreased.
  • both frozen and fresh osteochondral ALLOgraft material lack exact sizing capabilities, which vary in non-biologically identical patients.
  • An area harvested from the same area in a donor's femoral condyle does not exactly match that of the recipient in many cases.
  • the donor osteochondral graft is usually modified by the orthopedic surgeon in the operating room to fit better into the recipient site, which is not very precise and can be a rather lengthy undertaking.
  • ALLOgraft is problematic because of possible immunogenic response from the recipient against the implanted osteochondral tissue.
  • problems with cross-infection from the donor material to the recipient from numerous diseases including HIV, Hepatitis B have been reported.
  • Osteochondral AUTO graft material may also be harvested from the patient's native tissue in the same affected joint or from a different joint. This is problematic for several reasons. Firstly, the amount of tissue removed which is transferred to another diseased portion of the joint is small because one does not want to significantly compromise the structural integrity of an unaffected portion of the joint. Secondly the tissue and cell lines harvested are not expanded in vitro, thus limiting the amount of tissue to be implanted into the affected portion of the joint. Thirdly, the chondral tissue harvested within the same joint or another joint is difficult to match exactly in size, shape and contour to the area of the joint to be replaced. Finally, harvesting osteochondral tissue from another joint is possible, however requires additional surgery and morbidity.
  • the present invention also includes a custom, patient specific, 3-D printed guide for precise placement of osteochondral graft material that utilizes data obtained from radiologic imaging of the subject joint.
  • a method of repairing a defect on an articular surface of a bone within a joint includes acquiring a data set of a defect on an articular surface of a bone within a joint to be repaired by radiological imaging; evaluating the data set for the location of the defect; marking said defect with computer software; transferring said data with said marked defect to a 3-D printer and printing out a guide that demarcates said defect as a cut-out portion in said guide, said guide including a first guide reference element thereon; performing an osteochondral biopsy on an area of the damaged joint away from the defective area to obtain osteochondral cells; culturing the osteochondral biopsy cells to create a biogel; loading the biogel into a 3-D bioprinter to create an osteochondral tissue plug and hardening said osteochondral tissue plug to create an osteochondral AUTOgraft; inserting a second guide reference element into said biopsy site, said second guide reference element for matingly engaging said first guide reference
  • a 3-D printed guide structured to aid in the placement of osteochondral graft material on bone.
  • the 3-D printed guide includes a base portion that precisely mimics the surface of a bone or musculoskeletal tissue to be repaired, the base portion including a cut-out therewithin that corresponds to a defect on the surface of the bone or musculoskeletal tissue to be repaired; a first guide reference element 3-D printed on said base portion and configured to matingly engage a second guide reference element positioned on a surface of the bone or musculoskeletal tissue to be repaired.
  • FIG. 1A depicts an articular surface of femoral condyle showing an articular osteochondral defect to be repaired.
  • FIG. IB depicts a femoral condyle guide to be used in conjunction with the articular defect depicted in FIG. 1 A.
  • FIG. 2A depicts an exemplary surface of a tibial plateau showing the area of the defect to be repaired.
  • FIGS. 2B and 2C depict guides that may be used in conjunction with a tibial plateau central defect and tibial plateau marginal defect, respectively.
  • FIG. 3A depicts an articular surface of a trochlea showing the area of the defect to be repaired.
  • FIG. 3B depicts a guide that may be used in conjunction with the trochlea.
  • FIG. 4A depicts an articular surface of the patella showing the area of the defect to be repaired.
  • FIG. 4B depicts a guide that may be used in conjunction with the repair of the patella.
  • FIG. 5 depicts one aspect of the invention showing the articular surface to be repaired on a bone; a guide including a first reference guide element thereon and a cut-out area that replicates the size, shape, and thickness of the articular surface to be repaired; a second reference guide element inserted into the articular surface; and a bioprinted osteochondral or chondral graft to be placed in the articular surface.
  • FIG. 6A depicts a hole drilled at a biopsy site in the articular surface of a femur.
  • FIGS. 6B and 6C depicts a second guide reference element that is inserted into the hole of FIG. 6 A.
  • FIG. 7 illustrates the guide that may be used in the repair of an articular surface of a femur, the guide including a first guide reference element configured for mating with the second guide reference element of FIGS. 6B and 6C.
  • FIG. 8 illustrates the first guide reference element being placed in mating relationship with the second guide reference element.
  • FIG. 9 depicts placement of the guide on the articular surface of the femur exposing the defect in the articular surface subject to repair.
  • the present invention relates to a reproducible process that may be used to fabricate size-specific, customized bio-printed musculoskeletal tissue for use in various human and veterinary orthopedic applications.
  • Articular cartilage grafts and osteochondral grafts for implantation into any joint are described herein as exemplary.
  • the present invention may also be utilized with bone grafts, labral grafts, meniscal grafts, spine disc grafts and ligament grafts among other tissues. The process of the present invention will now be described.
  • the precise data obtained is also essential for the 3D creation of a precise guide, used to aid in accurate placement of the newly created chondral or osteochondral material.
  • the data set obtained from the CT images is evaluated for the location of the defects.
  • the area of the defect is then marked using CAD or SLS software as described below. After marking the area of the defect, the data is sent to a 3-D printer and the guide in accordance with the invention is printed out with the precise area of the defect cut-out from the guide.
  • the AUTOgraft (disclosed in detail below) is bioprinted to the exact shape of the cut-out.
  • osteochondral or chondral tissue can be cut into an exact shape using the CT data which defines the defect.
  • a polymeric covering is used instead of living tissue, this material can also be cut into the precise shape using the CT data which defines the defective area to be replaced.
  • Surgery will be performed using the guide to remove the damaged bone.
  • the bioprinted or possibly pre-surgically cut articular AUTOgraft will fit exactly into the cut-out on the guide and into the area of surgically removed bone.
  • the data set will be downloaded to a high resolution 3D printer.
  • An example of a 3D printer which may be modified and used is be the Projet 7000 HD (3D systems, Rock Hill, SC.) or other 3D printers.
  • the data transfer to the 3-D bioprinter may be achieved via download of data from a high definition CD disc or via streaming data via the Internet.
  • This data set because of its inherent high resolution will allow precise reconstruction of the tissue sampled.
  • the data will be manipulated or post processed on CAD or SLS software used by several companies (for example Terra recon, Vital Images). The data manipulation is important to remove any portion of the tissue that does not need to be replicated and to remove any artifacts. Only the tissue to be replicated will be sent to the printer for bio printing.
  • the same data created will also be sent to a 3D printing facility to create a precise template or guide which will act as a stencil to allow the surgeon to accurately address the diseased portion of the joint surface.
  • the newly created cell lines may be maintained in an aqueous state in methods known to those of skill in the art.
  • This liquid "biogel” or “bioink” will be the material used to create the new tissue.
  • the tissue will be loaded into a 3-D bio printer, possibly with bone gel and cartilage gel loaded separately.
  • the tissue in question will be bio printed, possibly on a mold created to model the tissue in question on sheets of biopaper.
  • the gel printed on to a template or mold may be "hardened” into a solid form. Exposure to UV light or compression is a possible mechanism to accomplish this task.
  • This new product will likely be an osteochondral tissue plug identical in size in the XYZ planes, however, likely not identical in consistency to articular cartilage.
  • a period of "tissue hardening" will likely be needed in order to mature the newly created osteochondral graft.
  • Mechanical stress to the tissue similar to that expected to occur in normal native tissue may be used in this process of "tissue hardening.” or other methods. This will result in a final tissue that is a new, precise AUTOlogous, customized bio printed osteochondral AUTOgraft.
  • an exact shaped bioprinted osteochondral graft corresponding exactly to the "cut out" in the guide and to the diseased joint surface will then be sterilely 3D bioprinted.
  • an osteochondral or chondral graft can be cut into a precise shape pre-operatively.
  • This osteochondral AUTOgraft will be the exact dimension and shape as the peripheral guide as depicted in the exemplary embodiments of FIGS. IB, 2B, 3B, and 4B, 5, 6A-C, 7, 8 and 9.
  • the data used to create the 3-D printed guide may be obtained from the recipient joint surface using high-resolution radiologic imaging (including, but not limited to CT, CT arthrogram, electron beam CT or CT orthography, MR or MR arthrogram).
  • the data may then be post processed using SLS software or other post processing software to identify the area of concern and optimize the 3-D printing of a guide.
  • SLS software or other post processing software to identify the area of concern and optimize the 3-D printing of a guide.
  • the guide has a unique 3-D shape which will fit over the recipient joint surface like a "hand in glove.”
  • the recipient joint surface has unique contours, depressions, ridges and osteophytes and therefore the 3-D printed guide will fit uniquely on the joint surface.
  • the guide is custom made to the patient's unique joint anatomy with differing shapes and contours from patient to patient.
  • first and second guide reference elements are referred to herein as first and second guide reference elements.
  • the first guide reference element may comprise a female portion while the second guide reference element may comprise a male portion.
  • the first guide reference element may comprise a male portion while the second guide reference element may comprise a female portion.
  • the important aspect of the guide reference elements is that they be in mating relationship with each other to secure the guide to the articular surface of the bone during the surgical procedure to repair the defect.
  • the 3-D Printed Guide Using standard surgical technique, the surface of the joint in question will be exposed. The guide will be placed on the recipient tissue surface as best illustrated in FIGS. 5, 8 and 9. The 3-D printed guide will have a "cut out” area in it, which corresponds to the portion of the surface of the joint which is damaged and needs to be to be replaced. The "cut out” portion will be determined from the previously obtained high resolution radiologic imaging. This "cutout” will guide the surgeon to the exact location of the damaged joint surface needing repair. The guide will act like a stencil, guiding the exact portion of the joint surface which needs to be replaced.
  • the surgeon may use a burr or other cutting device to debride the area of the joint surface bounded by the "cut out” area of the guide.
  • Tissue will be removed from inside of the guide to a precise, predetermined depth and the depth of the tissue removed will be limited by a gauge on the cutting device which articulates with the 3D printed guide.
  • a depth gauge will be placed on this tool to ensure uniform (accurate) depth of the defect created.
  • the 3D printed guide may have elevated (thicker) or depressed (thinner) portions on its non-articular side.
  • the areas of thicker guide will only allow shallower removal of diseased tissue, while the thinner guide areas will allow deeper removal of diseased tissue.
  • a precise depth or volume of diseased tissue can be precisely removed.
  • the surgically created defect left after using the cutting device will mimic the exact shape of the "cut out" area of the 3-D printed guide and will be of a customized, predetermined depth.
  • Implantation of Newly Created Bio Tissue After the foregoing process of using the 3D printed guide has been accomplished, the osteochondral AUTOgraft will be introduced into the recipient and the osteochondral AUTOgraft will be placed in the surgically created defect.
  • the osteochondral AUTOgraft will fit exactly in the defect in a "lock in key” manner, because the defect has been surgically created exactly to allow precise fit of the bioprinted osteochondral AUTOgraft.
  • the exact contour of the surface of the osteochondral graft will precisely follow the contour of the adjacent native tissue. This precise contour has been achieved by the precise bioprinting method described above using precise radiologic data.
  • the osteochondral or chondral tissue can be cut using the radiological data, into a precise 3D shape in order to fit exactly into the surgically created defect.
  • the implanted osteochondral AUTOgraft implanted will be held in place by the adjacent tissue in a "press fit” manner or may be fixed using bio-absorbable screws or pins or glue as has been described in the orthopedic literature or by any other appropriate means.
  • the joint may now be surgically closed in the standard fashion known to those of skill in the art.
  • the 3-D printed, customized guide may also be used with other available chondral replacement materials.
  • a 3D printed guide in accordance with the invention may be created to optimize precise placement of metallic, ceramic, porcelain and other types of orthopedic devices and prostheses in bones, joints and soft tissues.
  • the present invention may be used in, but not limited to, placement of total or partial joint surface replacement, bone replacement for bony defects, spine replacement and other types of musculoskeletal tissue replacement.
  • FIG. 1A depicts an articular surface 1 of a femoral condyle showing an articular osteochondral defect 5 to be repaired.
  • FIG IB depicts one aspect of a femoral condyle guide 10 in accordance with the invention to be used in conjunction with the articular defect 5 depicted in FIG. 1A.
  • Guide 10 includes a base portion 12, flange 14 and edge 16.
  • Edge 16 is configured to receive a sculpting tool or milling device known to those of skill in the art.
  • Flange 14 may include a plurality of openings that can be used to secure the guide 10 to the articular surface of the bone during surgery.
  • Guide 10 includes cut-out portion 18 which conforms precisely to the defect 5 being repaired.
  • FIG. 2A depicts another surface of a tibial plateau showing the area of the defect 5 to be repaired.
  • FIGS. 2B and 2C depict guides 10 that precisely conform to the articular surface of the bone to be repaired and may be used in conjunction with a tibial plateau central defect and tibial plateau marginal defect, respectively.
  • FIG. 3A depicts an articular surface of a trochlea showing the area of the defect 5 to be repaired.
  • FIG. 3B depicts a 3-D printed guide 10 that conforms precisely to the articular surface of the trochlea being repaired in FIG. 3A and which includes a cut-out portion 18 that precisely conforms to the area of the defect.
  • FIG. 4A depicts an articular surface of the patella showing the area of the defect 5 to be repaired
  • FIG. 4B depicts a guide 10 that may be used in conjunction with the repair of the patella.
  • the guide includes a base portion 12, flange 14 and edge 16.
  • Edge 16 is configured to receive a sculpting tool or milling device known to those of skill in the art.
  • Flange 14 may include a plurality of openings that can be used to secure the guide 10 to the articular surface of the bone during surgery.
  • guide 10 includes cut-out portion 18 which conforms precisely to the- defect 5 being repaired.
  • FIG. 5 depicts another aspect of the invention and shows the defect 5 on the articular surface 1 to be repaired.
  • a second guide reference element male guide pin 20
  • the biopsy site is used by way of convenience but the guide pin 20 may be inserted into other parts of the articular surface.
  • Guide 30 includes base portion 32 that is 3D printed from data acquired by radiologic imaging as previously discussed.
  • base portion 32 conforms precisely to the articular surface of the bone to be repaired.
  • cut-out portion 34 conforms precisely to the defect 5 to be repaired and precisely replicates the size, shape, and thickness of the articular defect 5.
  • Guide 30 may optionally include an edge 36 that is configured to receive a sculpting tool such as a burr or milling device.
  • Base portion 32 also includes first guide reference element, which is a female receiving guide pin opening 38 that matingly engages guide pin 20.
  • 3-D bioprinted osteochondral or chondral graft, polymeric covering, or cut chondral graft material 40 precisely conforms to the cut-out portion 34 and to the defect 5 and in operation is press-fit into the defect, which has been sculpted or milled to remove the damage.
  • FIGS 6, 7, 8 and 9 depict another aspect of the guide in accordance with the invention.
  • FIG. 6 A depicts hole 50 drilled at a biopsy site in the articular surface 1 of a femur.
  • Guide plug receiving thimble 60 includes a raised wall 62 surrounding floor 64.
  • the outer circumference of raised wall 62 may be substantially round to allow for convenient placing it into hole 50.
  • the inner circumference 66 of raised wall 62 may be in the shape of an arrowhead, arrow, square, round or may have any geometric shape such that the first guide reference element, male guide plug 72, as best seen in FIG. 8, matingly engages with it.
  • FIG. 7 illustrates the underside surface 71 of the 3-D bioprinted guide 70 that mates with the articular surface of a bone to be repaired.
  • the guide 70 includes cut-out 74 which is configured to precisely replicate the defect in the bone.
  • Guide 70 also includes first guide reference element, male guide plug 72, that is configured for mating with the second guide reference element, female guide plug receiving thimble 60.
  • FIG. 8 illustrates the guide 70 being placed on the articular surface 1 of the bone to be repaired.
  • Male guide plug 72 is shown being received in mating relationship with female guide plug receiving thimble 60.
  • FIG. 9 depicts placement of the guide 70 on the articular surface of the femur exposing the defect and area to be repaired.
  • a depth guide structured to engage and articulate with the 3-D printed guide may be utilized with any of the embodiments disclosed herein.

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  • Engineering & Computer Science (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

L'invention concerne un procédé de fabrication de tissu musculosquelettique de taille spécifique bio-imprimé personnalisé à l'aide de données tridimensionnelles collectées à partir d'imagerie radiologique. L'invention concerne également un guide qui est créé à partir d'imagerie radiologique qui délimite la zone d'intérêt chirurgical. Le guide est imprimé en 3D selon des dimensions de guidage collectées à partir de l'imagerie radiologique, comprenant notamment, mais pas exclusivement, des balayages d'imagerie CT, l'arthrographie CT, l'IRM, les ultrasons, l'arthrographie MR, ou toute autre modalité d'imagerie utilisée pour imager le système musculosquelettique.
PCT/US2015/014374 2014-04-21 2015-02-04 Système et procédé pour guides d'implantation imprimés en trois dimensions WO2015163966A1 (fr)

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US201461995749P 2014-04-21 2014-04-21
US61/995,749 2014-04-21
US201462123084P 2014-11-07 2014-11-07
US62/123,084 2014-11-07

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WO2017001028A1 (fr) * 2015-07-02 2017-01-05 Episurf Ip-Management Ab Système, outils de guidage et procédés de conception correspondants pour réaliser une chirurgie de transplantation ostéo-cartilagineuse dans une articulation
US10470887B2 (en) * 2015-08-27 2019-11-12 Institute of Orthopedic Research & Education Modification of the surface topography of cartilage grafts for joint reconstruction
EP3781333A4 (fr) 2018-04-17 2021-12-29 Stryker European Holdings I, LLC Personnalisation d'implant à la demande dans un contexte chirurgical
US11986251B2 (en) 2019-09-13 2024-05-21 Treace Medical Concepts, Inc. Patient-specific osteotomy instrumentation
WO2021051098A1 (fr) 2019-09-13 2021-03-18 Inmotus Medical Llc Procédés et instrumentation chirurgicaux robotisés

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US20110125003A1 (en) * 2008-05-29 2011-05-26 Yale University Systems, Devices and Methods For Cartilage and Bone Grafting
US8133234B2 (en) * 2006-02-27 2012-03-13 Biomet Manufacturing Corp. Patient specific acetabular guide and method
US8398646B2 (en) * 2006-06-09 2013-03-19 Biomet Manufacturing Corp. Patient-specific knee alignment guide and associated method
US20130191085A1 (en) * 2012-01-24 2013-07-25 Zimmer, Inc. Method and system for creating patient-specific instrumentation for chondral graft transfer
WO2013109708A1 (fr) * 2012-01-20 2013-07-25 Accelerated Orthopedic Technologies, Inc. Instruments, procédés et systèmes permettant de prélever et d'implanter des matériaux de greffe
WO2013155501A1 (fr) * 2012-04-13 2013-10-17 Conformis, Inc. Dispositifs d'arthroplastie d'articulation adaptés au patient, outils chirurgicaux et procédés d'utilisation

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US8133234B2 (en) * 2006-02-27 2012-03-13 Biomet Manufacturing Corp. Patient specific acetabular guide and method
US8398646B2 (en) * 2006-06-09 2013-03-19 Biomet Manufacturing Corp. Patient-specific knee alignment guide and associated method
US20110125003A1 (en) * 2008-05-29 2011-05-26 Yale University Systems, Devices and Methods For Cartilage and Bone Grafting
WO2013109708A1 (fr) * 2012-01-20 2013-07-25 Accelerated Orthopedic Technologies, Inc. Instruments, procédés et systèmes permettant de prélever et d'implanter des matériaux de greffe
US20130191085A1 (en) * 2012-01-24 2013-07-25 Zimmer, Inc. Method and system for creating patient-specific instrumentation for chondral graft transfer
WO2013155501A1 (fr) * 2012-04-13 2013-10-17 Conformis, Inc. Dispositifs d'arthroplastie d'articulation adaptés au patient, outils chirurgicaux et procédés d'utilisation

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